Periodontal disease and its treatment require an anatomic understanding of an important dental structure (i.e., physiological feature) known as the gingival crevice. This “gingival crevice” can be likened to how a turtleneck sweater fits around a person's neck. If one places a hand between one's neck and the turtleneck sweater, the intervening space could be likened to a gingival crevice. On one side of the hand, the neck could represent the white outer (enamel) surface of a tooth, or even the lower yellow part of the tooth's root surface. On the other side of the hand, the inside collar of the turtleneck sweater could represent the inside lining of the gum tissue surrounding a tooth. Again, the intervening space between the neck and turtleneck sweater would correspond to a gingival crevice.
It is well known that, immediately upon the completion of a dental cleaning, a distinct biological process begins. Saliva in the mouth coats the clean tooth, providing a sticky coating that attaches to the tooth structure. Bacteria in the mouth are then able to attach to the sticky coating and begin multiplying exponentially. During the bacterial lifecycle, the bacteria produce enzymes and toxins that are capable of entering the gingival crevice. Once inside the crevice, the bacteria release these enzymes and toxins which are able to create microscopic ulcers on the inside tissue wall of the gingival crevice. This can result in bleeding inside the gingival crevice, thus eventually allowing the bacteria to enter the microscopic holes created in the tissues of the gingival crevice. Once inside the gum tissue, the bacteria can destroy deeper structures such as connective tissues and blood vessels and could progress even deeper, perhaps eventually reaching and even destroying the bone that holds the teeth in place.
In the past, dental treatment has relied on the use of mechanical instruments to scrape the root and tooth structures that lie inside the gingival crevice in order to control the aforementioned disease process. There have even been attempts in the past to assist in the control of periodontal disease by using liquid or gel medications that are applied by thin metal or plastic syringe tips placed into the gingival crevice. Recently, however, the first “new generation” of time released sub-gingival powdered medications has been released commercially, as of the year 2001 (namely, the “ARESTIN” medication developed by Orapharma, Inc., of Warminster, Pa.). It is recognized that the administration of these and future medications will likely be dependent upon a syringe-like cartridge for application.
A current, conventional syringe tip is 1.5 mm wide on its outside tip diameter and will not easily begin to submerge into the gingival crevice; gingival crevices generally allow for the safe sub-gingival passage of structures that are, at a maximum, ½ mm wide. Another difficulty with this type of syringe/cartridge applicator is that it is rigid and cannot easily be angulated or rotated to reach many areas of the mouth. Therefore, a need has been recognized in connection with assisting in the application of medications to be placed inside the gingival crevice.
It is typical for the cell lining of the gingival crevice to adhere to the tooth's enamel or root surface. Ideally, then, the gingival crevice should be opened at its entry along the gum-line and then penetrated and expanded with deeper progression into the crevice. Maintaining this newly opened space is crucial in order to allow the medication to be applied in proper bulk and dosage. This means that the medication will easily enter the gingival crevice and fill up the potential space created by the assisting device.
Therefore, a need has been recognized in connection with providing an assisting device that may be reliably placed by a dentist. The device should preferably be constructed with enough strength and rigidity to withstand the biological resistances found in the tissue wall making up the gingival crevice. The device should also be readily adaptable to the medication applicator and yet be adjustable for individual patients. The device, also should not cause injury to the gingival crevice and should be comfortable for the patient.
A large need has thus been recognized in connection with providing an optimized, applicator-assisted device for delivering powdered medication.
In the context described hereinabove, the emergence of a time-released powdered medication since 2001 has increased the use of non-surgical treatment for periodontal diseases. Conventional plastic syringe tips used for the application of this (and future) medications is fraught with the following technical and biological problems:                1. The syringe tip is too large to enter the gingival crevice comfortably and safely.        2. The medications are unable to reach the bottom of the crevice in a consistent manner.        3. The syringe tip is unable to carefully maintain an open space in the gingival crevice that is large enough to hold a full dosage of the medication.        4. The application tip of the syringe is not adjustable enough to alter angulations in a way that allows the syringe tip to enter the gingival crevice.        5. The application tip of the syringe is not adjustable at all for rotational movement in a way that allows the syringe tip to enter the gingival crevice.        
Needs have thus also been recognized in connection with overcoming the above-listed problems and with providing a medication-assisting device that can be used in conjunction with an application syringe tip (or future applicator tips) of current and future medications.